Patient leaflet - OSELTAMIVIR 75 MG CAPSULE HARD
oseltamivir
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
-
– Keep this leaflet. You may need to read it again.
-
– If you have any further questions, ask your doctor or pharmacist.
-
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
-
1. What Oseltamivir Capsule, hard is and what it is used for
-
2. What you need to know before you take Oseltamivir Capsule, hard
-
3. How to take Oseltamivir Capsule, hard
-
4. Possible side effects
-
5. How to store Oseltamivir Capsule, hard
-
6. Contents of the pack and other information
1. what oseltamivir capsule, hard is and what it is used for
- Oseltamivir Capsule, hard is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.
- Oseltamivir Capsule, hard can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis – for instance, if you have been in contact with someone who has flu.
- Oseltamivir Capsule, hard may be prescribed for adults, adolescents, children and infants (including full-term newborn babies) as preventive treatment in exceptional circumstances – for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.
Oseltamivir Capsule, hard contains oseltamivir , which belongs to a group of medicines named neuraminidase inhibitors. These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the symptoms of the flu virus infection.
Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden fever (more than 37.8°C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics ) when flu viruses are spreading in the local community. Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.
2. what you need to know before you take oseltamivir capsule, harddo not take oseltamivir capsule, hard if you are allergic to oseltamivir or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Oseltamivir Capsule, hard:
- if you are allergic to other medicines
- if you have problems with your kidneys. If so, your dose may need adjustment
- if you have a severe medical condition, which may require immediate hospitalisation
- if your immune system is not working
- if you have chronic heart disease or respiratory disease.
During treatment with Oseltamivir Capsule, hard, tell a doctor immediately :
- if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents. These may be signs of rare but serious side effects.
Oseltamivir Capsule, hard is not a flu vaccine
Oseltamivir Capsule, hard is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you antibodies against the virus. Oseltamivir Capsule, hard will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.
Other medicines and Oseltamivir Capsule, hard
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. The following medicines are particularly important:
chlorpropamide (used to treat diabetes)
methotrexate (used to treat e.g. rheumatoid arthritis) phenylbutazone (used to treat pain and inflammation) probenecid (used to treat gout)
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide if Oseltamivir Capsule, hard is right for you.
The effects on breast-fed infants are unknown. You must tell your doctor if you are breastfeeding so that your doctor can decide if Oseltamivir Capsule, hard is right for you.
Driving and using machines
Oseltamivir Capsule, hard has no effect on your ability to drive or use machines.
Oseltamivir Capsule, hard contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
3. how to take oseltamivir capsule, hard
Take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take Oseltamivir Capsule, hard as soon as possible, ideally within two days of the flu symptoms starting.
The recommended doses
For treating flu , take two doses daily. It is usually convenient to take one dose in the morning and one in the evening. It is important to complete the whole 5-day course , even if you start to feel better quickly.
For adult patients with a weak immune system, treatment will continue for 10 days.
For preventing flu or after being exposed to an infected person , take one dose daily for 10 days. It is best to take this in the mornings with breakfast.
In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.
The recommended dose is based on the patient’s body weight. You must use the amount of oral capsules prescribed by the doctor.
Adults, and adolescents 13 years and over
| Body weight | Treating flu: dose for 5 days | Preventing flu: dose for 10 days |
| 40 kg or more | 75 mg twice daily | 75 mg once daily |
75 mg can be made up of a 30 mg capsule plus a 45 mg capsule
Children 1 to 12 years
| Body weight | Treating flu: dose for 5 days | Preventing flu: dose for 10 days |
| 10 to 15 kg | 30 mg twice daily | 30 mg once daily |
| More than 15 kg and up to 23 kg | 45 mg twice daily | 45 mg once daily |
| More than 23 kg and up to 40 kg | 60 mg twice daily | 60 mg once daily |
| More than 40 kg | 75 mg twice daily | 75 mg once daily |
75 mg can be made up of a 30 mg capsule plus a 45 mg capsule
Infants less than 1 year (0 to 12 months)
Giving oseltamivir to infants less than 1 year old for preventing flu during flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant. ____________________________________________________________
| Body weight | Treating flu: dose for 5 days | Preventing flu: dose for 10 days |
| 3 kg to 10+ kg, | 3 mg per kg body weight, twice daily | 3 mg per kg, once daily |
| mg per kg = mg for each kilogram of t If a 6-month-old weighs 8 kg, the dose 8 kg x 3 mg per kg = 24 mg | he infant’s body weight. For example: is | |
Method of administration
Swallow the capsules whole with water. Do not break or chew the capsules.
Oseltamivir Capsule, hard can be taken with or without food, although taking it with food can reduce the chance of feeling or being sick (nausea or vomiting).
People who find it hard to take capsules a liquid medicine, oseltamivir powder for oral suspension, may be available and is the preferred product. If you need a liquid medicine but it is not available, a suspension can be made up at the pharmacy from Oseltamivir Capsule, hard (see Information for healthcare professionals). If the pharmacy preparation is also not available you can make a liquid form of Oseltamivir Capsule, hard from these capsules. See Making liquid Oseltamivir Capsule, hard at home , over the page.
If you take more Oseltamivir Capsule, hard than you should
Stop taking Oseltamivir Capsule, hard and contact a doctor or pharmacist immediately.
In most cases of overdose, people have not reported any side effects. When side effects were reported, they were similar to those from normal doses, as listed in section 4.
Overdose has been reported to have occurred more frequently when oseltamivir was given to children than to adults and adolescents. Caution should be exercised when preparing liquid Oseltamivir Capsule, hard for children and when administering Oseltamivir Capsule, hard or liquid Oseltamivir Capsule, hard to children.
If you forget to take Oseltamivir Capsule, hard
Do not take a double dose to make up for a forgotten capsule.
If you stop taking Oseltamivir Capsule, hard
There are no side effects when you stop Oseltamivir Capsule, hard. But if Oseltamivir Capsule, hard is stopped earlier than your doctor told you, the symptoms of flu may come back. Always complete the course that your doctor prescribed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side effects listed below may also be caused by influenza (flu).
The following serious side effects have been rarely reported since oseltamivir has been marketed:
- Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties
- Liver problems (fulminant hepatitis, liver function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool color, changes in behaviour
Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly lifethreatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue (tiredness), skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure
Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood
Neuropsychiatric disorders, as described below.
If you notice any of these symptoms, get medical help immediately.
Other side effects:
The most frequently (very common and common) reported side effects of oseltamivir are feeling or being sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects mostly occur after the first dose of the medicine and will usually stop as treatment continues. The frequency of these effects is reduced if the medicine is taken with food.
Rare but serious effects: get medical help at once
(may affect up to 1 in 1,000 people)
During oseltamivir treatment, rare events have been reported that include
Convulsions and delirium, including altered level of consciousness
Confusion, abnormal behaviour
- Delusions, hallucinations, agitation, anxiety, nightmares
These are reported primarily among children and adolescents and often started suddenly and resolved rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events have also been reported in patients with influenza who were not taking oseltamivir.
Patients, especially children and adolescents, should be closely monitored for the
behavioural changes described above.
If you notice any of these symptoms , especially in younger people, get medical help immediately.
Adults and adolescents 13 and over
Very common side effects (may affect more than 1 in 10 people)
- Headache
- Nausea.
Common side effects (may affect up to 1 in 10 people)
- Bronchitis
- Cold sore virus
- Cough
- Dizziness
- Fever
- Pain
- Pain in limb
- Runny nose
- Sleeping difficulties
- Sore throat
- Stomach ache
- Tiredness
- Upper abdominal fullness
- Upper respiratory tract infections (inflammation of the nose, throat and sinuses)
- Upset stomach
- Vomiting.
Uncommon side effects (may affect up to 1 in 100 people)
- Allergic reactions
- Altered level of consciousness
- Convulsion
- Heart rhythm abnormalities
- Mild to severe liver function disorders
- Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).
Rare side effects (may affect up to 1 in 1,000 people)
- Thrombocytopenia (low platelet count)
- Visual disturbances.
Children 1 to 12 years
Very common side effects (may affect more than 1 in 10 people)
- Cough
- Nasal congestion
- Vomiting.
Common side effects (may affect up to 1 in 10 people)
- Conjunctivitis (red eyes and discharge or pain in the eye)
- Ear inflammation and other ear disorders
- Headache
- Nausea
- Runny nose
- Stomach ache
- Upper abdominal fullness
- Upset stomach.
Uncommon side effects (may affect up to 1 in 100 people)
- Inflammation of the skin
- Tympanic membrane (eardrum) disorder.
Infants less than 1 year
The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older). Additionally, diarrhoea and diaper rash have been reported.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. However,
- if you or your child are repeatedly sick, or
- if the influenza symptoms get worse or the fever continues
Tell your doctor as soon as possible.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system Yellow Card Scheme, Website:or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store oseltamivir capsule, hard
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other informationwhat oseltamivir capsule, hard containsthe active substance is oseltamivir.
- Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir
- The other ingredients are:
capsule contents: pregelatinised starch, croscarmellose sodium, povidone, sodium stearyl fumarate, and talc
capsule shell: gelatin and titanium dioxide (E171)
printing ink: shellac, potassium hydroxide and black iron oxide (E172)
- Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir
- The other ingredients are:
capsule contents: pregelatinised starch, croscarmellose sodium, povidone, sodium stearyl fumarate, and talc
capsule shell: gelatin, iron oxide yellow and titanium dioxide (E171)
printing ink: shellac, FD&C Blue No.1 (E133) and titanium dioxide (E171)
- Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir
- The other ingredients are:
capsule contents: pregelatinised starch, croscarmellose sodium, povidone, sodium stearyl fumarate, and talc
capsule shell: gelatin, FD&C Blue No.1 (E133), quinoline yellow and titanium dioxide (E171)
printing ink: shellac, potassium hydroxide and black iron oxide (E172)
What Oseltamivir Capsule, hard looks like and contents of the pack
The hard capsule consists of a white opaque body without any imprint and a white opaque cap bearing the imprint “S5”. Imprints are black.
Oseltamivir 30 mg Capsule, hard is available in blister packs of 10.
The hard capsule consists of a white opaque body without any imprint and a buff opaque cap bearing the imprint “S4”. Imprint is blue.
Oseltamivir 45 mg Capsule, hard is available in blister packs of 10.
The hard capsule consists of a white opaque body without any imprint and a light green opaque cap bearing the imprint “S2”. Imprint is black.
Oseltamivir 75 mg Capsule, hard is available in blister packs of 10.
Marketing Authorisation Holder
HEC Pharm GmbH
Gabriele-Tergit-Promenade 17
10963 Berlin, Germany
Tel.: 030–3300 7721
Manufacturer
Formula Pharmazeutische und chemische Entwicklungs GmbH Goerzallee 305b 14167 Berlin
Germany
This medicinal product is authorised in the Member States under the following names:
| Germany | Oseltamivir HEC Pharm 30 mg Hartkapseln |
| Oseltamivir HEC Pharm 45 mg Hartkapseln | |
| Oseltamivir HEC Pharm 75 mg Hartkapseln | |
| United | Oseltamivir 30 mg Capsule, hard |
| Kindom | Oseltamivir 45 mg Capsule, hard |
| Oseltamivir 75 mg Capsule, hard | |
| France | OSELTAMIVIR HEC PHARM 30 mg, gelule |
| OSELTAMIVIR HEC PHARM 45 mg, gelule | |
| OSELTAMIVIR HEC PHARM 75 mg, gelule | |
| Italy | Oseltamivir HEC Pharm |
| Oseltamivir HEC Pharm | |
| Oseltamivir HEC Pharm | |
| Spain | Oseltamivir HEC Pharm 30 mg capsulas duras |
| Oseltamivir HEC Pharm 45 mg capsulas duras | |
| Oseltamivir HEC Pharm 75 mg capsulas duras |
This leaflet was last revised in 05/2020.
Information for the user
For people who find it hard to take capsules , including very young children, a liquid medicine, oseltamivir powder for oral suspension, may be available and is the preferred product. If you need a liquid medicine but it is not available, a suspension can be made up at the pharmacy from Oseltamivir Capsule, hard (see Information for healthcare professionals ).
If the pharmacy preparation is not available either, you can make liquid Oseltamivir Capsule, hard from these capsules at home.
The dose is the same for treating or preventing flu. The difference is how often it is given.
Making liquid Oseltamivir Capsule, hard at home
- If you have the right capsule for the dose needed (a 30 mg or a 60 mg a 45 mg a 75 mg dose), you will open the capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product. This is usually suitable for children over 1 year. See the upper set of instructions.
- If you need smaller doses, making liquid Oseltamivir Capsule, hard from capsules involves extra steps. This is suitable for younger children and babies: they usually need a oseltamivir dose of less than 30 mg. See the lower set of instructions.
Children 1 to 12 years
Children 1 to 12 years
Adults, adolescents 13 years and over, and children weighing 40 kg and over
To make a 30 mg or a 60 mg dose, you need:
- One or two 30 mg Oseltamivir Capsule, hard
To make 45 mg dose, you need:
- One 45 mg Oseltamivir Capsule, hard
To make 75 mg dose, you need:
- One 75 mg Oseltamivir Capsule, hard
- Sharp scissors
- One small bowl
- Teaspoon (5 ml spoon)
- Water
- Sweet food to hide the bitter taste of the powder.
Examples are: chocolate or cherry syrup, and dessert toppings such as caramel or fudge sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.
Step 1: Check the dose is correct
To find the correct amount to use, find the patient’s weight on the left of the table.
Look at the right column to check the number of capsules you will need to give the patient for a single dose. The amount is the same whether treating or preventing flu.
You should use only 30 mg capsules for 30 mg and 60 mg doses. Do not try to make a 45 mg or 75
| mg dose by using the contents o | f 30 mg capsules. Use the appropriate size capsule instead. | |
| Weight | Dose of Oseltamivir Capsule, hard | Number of capsules |
| Up to 15 kg | 30 mg | 1 capsule |
| 15 kg up to 23 kg | 45 mg | Do not use 30 mg capsules |
| 23 kg up to 40 kg | 60 mg | 2 capsules |
Step 1: Check the dose is correct
To find the correct amount to use, find the patient’s weight on the left of the table.
Look at the right column to check the number of capsules you will need to give the patient for a single dose. The amount is the same whether treating or preventing flu.
45 mg dose S4
You should use only 45 mg capsules for 45 mg doses. Do not try to make a 30 mg, 60 mg or 75 mg dose by using the contents of 45. mg capsules. Use the appropriate size capsule instead. ___________
| Weight | Dose of Oseltamivir Capsule, hard | Number of capsules |
| Up to 15 kg | 30 mg | Do not use 45 mg capsules |
| 15 kg up to 23 kg | 45 mg | 1 capsule |
| 23 kg up to 40 kg | 60 mg | Do not use 45 mg capsules |
Step 1: Check the dose is correct
To find the correct amount to use, find the patient’s weight on the left of the table.
Look at the right column to check the number of capsules you will need to give the patient for a single dose. The amount is the same whether treating or preventing flu.
75 mg dose
You should use only 75 mg capsules for 75 mg doses. Do not try to make a 75 mg dose by using the contents of 30 mg or 45 mg capsules.
| Weight | Dose of Oseltamivir Capsule, hard | Number of capsules |
| 40 kg and over | 75 mg | 1 capsule |
Not for children who weigh less than 40 kg
You will need to prepare a dose of less than 75 mg for children who weigh less than 40 kg.
See below.
Step 2: Pour all the powder into a bowl
Hold a 30 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors.
Pour all of the powder into the bowl.
Open a second capsule for a 60 mg dose. Pour all of the powder into the bowl.
Be careful with the powder, because it may irritate your skin and eyes.
Step 2: Pour all the powder into a bowl
Hold a 45 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors.
Pour all of the powder into the bowl.
Be careful with the powder, because it may irritate your skin and eyes.
Step 2: Pour all the powder into a bowl
Hold a 75 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors.
Pour all of the powder into the bowl.
Be careful with the powder, because it may irritate your skin and eyes.
Step 3: Sweeten the powder and give the dose
Add a small amount – no more than one teaspoonful – of sweet food to the powder in the bowl.
This is to hide the bitter taste of the Oseltamivir Capsule, hard powder.
Stir the mixture well.
Give the whole contents of the bowl to the patient straight away.
If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get the patient to drink it all.
Repeat this procedure every time you need to give the medicine.
Infants less than 1 year
Infants less than 1 year
Infants less than 1 year, and children weighing less than 40 kg
To make a smaller single dose, you need:
- One 30 mg Oseltamivir Capsule, hard
- One 45 mg Oseltamivir Capsule, hard
- One 75 mg Oseltamivir Capsule, hard
- Sharp scissors
- Two small bowls (use separate pairs of bowls for each child)
- One large oral dose dispenser to measure out water – a 5 or 10 ml dispenser
- One small oral dose dispenser showing measurements of 0.1 ml, to give the dose
- Teaspoon (5 ml spoon)
- Water
- Sweet food to hide the bitter taste of the Oseltamivir Capsule, hard.